# US 10,945,845 B2 · Tissue repair devices and scaffolds > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,945,845 B2 - Document ID: US10945845B2 - Status: Granted - Kind: B2 - Application number: 14/402,737 - Filed: 2013-05-30 - Published: 2015-06-04 - Granted: 2021-03-16 - Earliest claimed: 2012-05-30 - Assignees: New York University - Applicants: New York University - Inventors: John L. Ricci; Elizabeth Clark; Paulo Coelho; Elizabeth Dianne Rekow; James Smay; Van P. Thompson - Web page: https://patentgrep.com/patent/US10945845B2 ## CPC - A61F 2/28: Bones - A61F 2/2875: {Skull or cranium (A61F2/2803 takes precedence; joints for temporo-mandibular [TM] joints [TMJ] A61F2/3099)} - A61L 27/025: {Other specific inorganic materials not covered by A61L27/04 - A61L27/12} - A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)} - A61L 27/56: Porous materials, {e.g. foams or sponges} - B33Y 80/00: Products made by additive manufacturing - A61F 2/3094: {Designing or manufacturing processes} - A61F 2002/2817: {Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]} - A61F 2002/30011: {differing in porosity} - A61F 2002/30235: {tubular, e.g. sleeves} - A61F 2002/30574: {with an integral complete or partial collar or flange} - A61F 2002/3092: {having an open-celled or open-pored structure} - A61F 2002/30962: {using stereolithography} - A61F 2002/30968: {Sintering} - A61F 2002/30985: {using three dimensional printing [3DP]} - A61F 2310/00179: Ceramics or ceramic-like structures - A61L 2430/02: for reconstruction of bones; weight-bearing implants - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - B33Y: ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING ## Abstract The present invention relates to multiphasic, three-dimensionally printed, tissue repair devices or scaffolds useful for promoting bone growth and treating bone fracture, defect or deficiency, methods for making the same and methods for promoting bone growth and treating bone fracture, defect or deficiency using the same. The scaffold has a porous bone ingrowth area containing interconnected struts surrounded by a microporous shell. At the ends of the scaffold, the shell may be extended as a guide flange to stabilize the scaffold between ends of bone. The center of the scaffold may be empty and may serve as a potential marrow space. The porous ingrowth structure may be infiltrated with a soluble filler or carrier, such as, for example calcium sulfate which may be infiltrated with one or more of an antibiotic, a growth factor, a differentiation factors, a cytokine, a drug, or a combination of these agents. ## Claims ### Claim 1 A tissue repair device or scaffold comprising: a porous bone ingrowth structure formed and shaped to customize the shape of tissue or bone repair desired to optimally span a defect so as to customize bone growth, wherein the porous bone ingrowth structure comprises interconnected struts formed by ejecting a colloidal ink from a print nozzle during a three dimensional printing process, wherein the colloidal ink consists essentially of ceramic particles in a water-based slurry comprising organic chemicals that control handling of the colloidal ink, wherein the interconnected struts comprise resorbable components to provide additional space for bone ingrowth over time, and wherein the interconnected struts define mesopores for bone ingrowth; and a microporous shell surrounding the porous bone ingrowth structure. ### Claim 2 (depends on 1) A tissue repair device or scaffold according to claim 1 wherein the microporous shell is extended as a guide to stabilize the tissue repair device or scaffold between one or more ends of bone. ### Claim 3 (depends on 1) The tissue repair device or scaffold according to claim 1 having a center defined by an empty space. ### Claim 4 (depends on 1) The tissue repair device or scaffold according to claim 1 wherein the porous ingrowth structure is infiltrated with a soluble filler or a soluble carrier. ### Claim 5 (depends on 4) The tissue repair device or scaffold according to claim 4 wherein the soluble filler or the soluble carrier comprises calcium sulfate. ### Claim 6 (depends on 4) The tissue repair device or scaffold according to claim 4 wherein the soluble filler or the soluble carrier comprises one or more of an antibiotic, a growth factor, a differentiation factor, a cytokine, a drug, or a combination thereof. ### Claim 7 (depends on 1) The tissue repair device or scaffold according to claim 1 wherein each of the interconnected struts has a diameter in a range from 100-350 μm. ### Claim 8 (depends on 1) The tissue repair device or scaffold according to claim 1 wherein each of the interconnected struts has a diameter in a range from 2× to substantially the same diameter as bone trabeculae. ### Claim 9 (depends on 1) The tissue repair device or scaffold according to claim 1 wherein at least two of the interconnected struts are separated longitudinally by an intervening empty space of at least 500 μm. ### Claim 10 (depends on 1) The tissue repair device or scaffold according to claim 1 being porous and comprising mesopores present in a size generally more than about 20 μm diameter. ### Claim 11 (depends on 1) The tissue repair device or scaffold according to claim 1 wherein the interconnected struts are arranged in a substantially linear arrangement. ### Claim 12 (depends on 1) The tissue repair device or scaffold according to claim 1 wherein, after about 8 weeks presence in vivo, at least about 25% of the tissue repair device or scaffold is resorbed. ### Claim 13 (depends on 1) The tissue repair device or scaffold according to claim 1 being at least about 50% porous. ### Claim 14 (depends on 1) The tissue repair device or scaffold according to claim 1 being operable to encourage and provide bone growth such that after about 8 weeks presence in vivo, at least about 25% of the tissue repair device or scaffold is replaced by bone. ### Claim 15 (depends on 1) The tissue repair device or scaffold according to claim 1 comprising micropores or nanopores having a diameter of about 0.1-1 nm. ### Claim 16 (depends on 15) The tissue repair device or scaffold according to claim 15 wherein one or more micropores or nanopores are infiltrated with solubilized collagen. ### Claim 17 (depends on 1) A method for promoting bone growth or treating bone fracture, defect or deficiency, the method comprising providing a tissue repair device or scaffold according to claim 1 in vivo to a region featuring a bone deficiency, fracture or void. ### Claim 18 (depends on 1) The tissue repair device or scaffold according to claim 1 wherein the interconnected struts comprise permanent components to provide long-term strength. ### Claim 19 (depends on 1) The tissue repair device or scaffold according to claim 1 wherein: the tissue repair device or scaffold printed in an oil bath; the tissue repair device of scaffold is removed from the oil bath and cured in a furnace. ### Claim 20 (depends on 1) The tissue repair device or scaffold according to claim 1 wherein the ceramic particles comprise one or more of hydroxyapatite (HA) ceramics and tricalcium phosphate ceramics (TCP). ### Claim 21 (depends on 1) The issue repair device or scaffold accordingly to claim 1 wherein: the interconnected struts comprise layers of nested concentric circular struts and layers of radially oriented struts; and one or more of the layers of radially oriented struts are disposed between adjacent layers of the nested circular struts. ### Claim 22 (depends on 21) The issue repair device or scaffold accordingly to claim 21 wherein nested concentric circular struts and the radially oriented struts combine to define mesopores providing a radially continuously variable porosity. ### Claim 23 (depends on 1) The issue repair device or scaffold accordingly to claim 1 wherein the three dimensional printing process is a three dimensional direct writing process. ### Claim 24 A method of producing a tissue repair device or scaffold useful for promoting bone growth or treating bone fracture, defect or deficiency, the method comprising: forming a porous bone ingrowth structure and a microporous shell that surrounds the porous bone ingrowth structure by ejecting a colloidal ink from a print nozzle during a three dimensional printing process, wherein the colloidal ink consists essentially of ceramic particles in a water-based slurry comprising organic chemicals that control handling of the colloidal ink, wherein the interconnected struts comprise resorbable components to provide additional space for bone ingrowth over time, wherein the interconnected struts define mesopores for bone ingrowth, wherein the porous bone ingrowth structure is formed and shaped to customize the shape of tissue or bone repair desired to optimally span a defect and infiltrating the porous bone ingrowth structure with a soluble filler or soluble carrier. ### Claim 25 (depends on 24) A method according to claim 24 wherein the soluble filler or soluble carrier comprises one or more of an antibiotic, a growth factor, a differentiation factor, a cytokine, a drug, or a combination of these agents. ### Claim 26 (depends on 24) The method according to claim 24, wherein the three dimensional printing process is a three dimensional direct writing process.